The FIBRINOGEN study; to evaluate and compare the ex vivo effects of recombinant human fibrinogen (rhFGN) , variants rhFbgAa610 and Aa847, and Haemocomplettan supplementation on blood coagulation

The FIBRINOGEN study; to evaluate and compare the ex vivo effects of recombinant human fibrinogen (rhFGN) , variants rhFbgAa610 and Aa847, and Haemocomplettan supplementation on blood coagulation - FIBRINOGEN study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON34478

Enrollment

Registered

2010-11-05

Start date

2010-12-06

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

coagulation disturbance coagulopathy

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Coronary artery bypass graft (CABG), isolated and on-pump - Preoperative fibrinogen level 35% - Age >18 years

Exclusion criteria

Exclusion criteria: - Any other procedure than on-pump CABG - Preoperative fibrinogen level >3,8g/L - Emergency surgery - History of bleeding diathesis or coagulopathy - Participation in any study involving an investigational drug or device - Inability to understand the study information and/or sign informed consent - Usage of FFPs or fibrinogen before or during the CABG procedure

Design outcomes

Primary

Measure	Time frame
Several parameters will be studied in the collected blood samples, e.g.: - ROTEM analysis - clotting time - clot formation time - maximum clot firmness - clot firmness after 10 minutes - clot firmness after 20 minutes - lysis onset time - lysis time - Coagulation and fibrinolysis activation assays	—

Secondary

Measure	Time frame
NVT	—

Countries

Netherlands

Outcome results